1. IRBshare: Streamlining IRB Review of Multisite Studies EMILY SHEFFER, MPA | VANDERBILT UNIVERSITY MEDICAL CENTER | EMILY.SHEFFER@IRBSHARE.ORG

2. IRBshare Background  NCRR/NCATS funded conference series grant (PI – Bernard)  IRB isolation + inefficiencies  Diverse experts from across the US  Met yearly June 2011-October 2014 Institutional Representatives CTSA Leadership, IRB Directors, Lawyers, Clinical Trial Experts Sponsors Sponsors Eli Lily, NIH, VA Regulatory Expertise Regulatory Expertise OHRP, AAHRPP, WIRB

3. IRBshare Shared Review Model 1.Local investigator submits study to local IRB 2.Study reviewed according to risk level (expedited or full committee review) upload 1.Local investigator submits study to local IRB (perhaps abbrev application) 2.Study reviewed by local subcommittee (>1 IRB member) using IRBshare documents LEAD IRB LOCAL OVERSIGHT IRB Committee Responsibility: 1.Determine whether study meets all federal regulatory guidelines for approval of research (e.g., 45 CFR 46.111) Subcommittee Responsibility: 1.Verify Lead IRB’s determination, AND 2.Review for site’s own local context issues IRB application Consent form(s) Protocol + IB/Device Manual Meeting minutes (redacted) Determination letter download

4. IRBshare is NOT a Central IRB WHY?  IRBshare minimizes burden on Lead IRB  IRBshare is established and free to use (for studies and sites)  IRBshare uses a single master agreement and can be used with ANY study regardless of disease type, funder, or type of review required  IRBshare maintains local IRB autonomy and control, as preferred by some IRBs  IRBshare provides transparency to promote consistent determinations, sharing of best practices, and communication between IRBs

5. IRBshare Scope and Eligibility  Institutions  Any institution with an FWA and federally constituted IRB  AAHRPP not required, but captured for relying sites’ decision making  Studies  All diseases and conditions  All studies that require IRB review  All funders: Federal, industry, and investigator-initiated  IRB Reviews Included  All Phase of Review: Initial study review, continuing review, and reviews of amendments Blue = new; included after pilot

6. IRBshare Progress FEBRUARY 2013-CURRENT

7. IRBshare Utilization: Sites

8. IRBshare Network (n=57) *AAHRPP accredited (n=42); †CTSA institution (n=38) States (n=28): Alabama Arizona Arkansas California Florida Illinois Iowa Kansas Kentucky Louisiana Maine Massachusetts Michigan Mississippi Minnesota New Mexico New York North Carolina Ohio Oregon Pennsylvania South Carolina Tennessee Texas Utah Virginia West Virginia Washington (Washington DC) Baystate Health*Northwestern University †University of Illinois Chicago*† Boston University Medical Center*†Oregon Health & Science University†University of Iowa*† Children’s National Medical Center*†Pennington Biomedical Research Center*University of Kansas*† Cincinnati Children’s Hospital Medical Center*†St. Claire Regional Medical CenterUniversity of Kentucky*† Columbia University*†Seattle Children’s HospitalUniversity of Miami† Duke University*†Stanford University*†University of New Mexico Health Sciences Center*† Louisiana State University A & M*Texas A&M UniversityUniversity of North Carolina at Chapel Hill *† Louisiana State University HSC New Orleans*The Rockefeller University*†University of Pennsylvania*† Louisiana State University HSC Shreveport*The Scripps Research Institute†University of Pittsburgh*† Maine Medical Center*The University of Arizona*University of Southern California*† Marshall University*The University of Texas HSC at Houston*†University of Texas HSC at San Antonio*† Medical University of South Carolina*†The University of Utah*†University of Texas Southwestern Medical Center† Mayo Clinic*†Tufts Medical Center†University of Washington† Meharry Medical College†Tufts University †Vanderbilt University*† Michigan State University*Tulane University*Virginia Commonwealth University*† Mississippi State University*University of Alabama Birmingham*†Wake Forest University Health Sciences* Mount Sinai Medical School*†University of Arkansas for Medical Sciences*†Washington University (St. Louis) *† New York University School of Medicine*†University of California, San Diego†West Virginia University* North Shore LIH Health SystemUniversity of California, San Francisco*†Xavier University (Louisiana)

9. # of studies [Median of 14 days from IRB submission to approval for relying sites] IRBshare Utilization: Studies

10. Lessons Learned Challenges  Outreach to investigators and funders  Varied reduction in workload for IRBs  IRBs use multiple reliance options; IRBshare should facilitate multiple models Successes  Quickly receive IRB approval  Transparency promotes consistency  National network evolving

11. Using IRBshare

12. Coordinating Use of IRBshare 1.Identifying a Lead IRB ◦Naturally occurring (1 st with IRB approval) ◦Select IRB based on experience, IRB willingness, site visit schedule 2.While Lead IRB seeking approval ◦Recruit non-IRBshare sites ◦Site investigators notify IRB of study + IRBshare; inquire about submission procedures 3.Once Lead IRB has approval, disseminate approved documents to other study sites ◦Approved consent becomes model consent 4.Site investigators submit (initial, continuing and amendment reviews) and report (adverse events) to the local IRB following local submission policies ◦Local IRB uses streamlined review to approve ◦Follow study protocol/direction from sponsor when reporting serious adverse events

13. Industry-sponsor Registration IRBs not on project whitelist cannot access study documents IRBshare Admin adds sites to project per sponsor instruction

14. Lead IRB Shares Approval Documents

15. Project Page: Uploading approvals and documenting reliances